Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Summary

This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.

Conditions

• Advanced Malignant Solid Neoplasm
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Locally Advanced Malignant Solid Neoplasm
• Malignant Female Reproductive System Neoplasm
• Metastatic HER2-Negative Breast Carcinoma
• Metastatic Malignant Solid Neoplasm
• Recurrent Endometrial Carcinoma
• Recurrent Fallopian Tube Carcinoma
• Recurrent Malignant Female Reproductive System Neoplasm
• Recurrent Malignant Solid Neoplasm
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Unresectable HER2-Negative Breast Carcinoma
• Unresectable Malignant Solid Neoplasm

Interventions

DRUG

Alpelisib

Given PO

DRUG

Binimetinib

Given PO

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Fluorouracil

Given IV

DRUG

Fulvestrant

Given IM

DRUG

Ipatasertib

Given PO

DRUG

Leucovorin

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Mutation Carrier Screening

Undergo tumor mutational screening

DRUG

Neratinib Maleate

Given PO

DRUG

Nilotinib Hydrochloride Monohydrate

Given PO

DRUG

Olaparib

Given PO

DRUG

Oxaliplatin

Given IV

DRUG

Paclitaxel

Given PO or IV

DRUG

Palbociclib

Given PO

BIOLOGICAL

Panitumumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET

DRUG

Selumetinib Sulfate

Given PO

DRUG

Sotorasib

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• James M Ford · ECOG-ACRIN Cancer Research Group

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-07

Primary Completion

2030-07-01

Completion

2030-07-01

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations